MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-130PA; TRANSMITTER

Model Number GZ-130PA

Device Problems Communication or Transmission Problem (2896); Loss of Data (2903); Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported that this unit is having frequent and lengthy communication loss (comm loss).Also, when batteries are being changed, the unit will not hold data and will dump the patient information.This causes the nurses to admit the patient again.The customer will send in the unit to be exchanged.There was no patient injury reported.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.

Event Description

The customer reported that this unit is having frequent and lengthy communication loss (comm loss).Also, when batteries are being changed, the unit will not hold data and will dump the patient information.There was no patient injury reported.

Event Description

The customer reported that this unit is having frequent and lengthy communication loss (comm loss).Also, when batteries are being changed, the unit will not hold data and will dump the patient information.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that this unit is having frequent and lengthy communication loss (comm loss).Also, when batteries are being changed, the unit will not hold data and will dump the patient information.This causes the nurses to admit the patient again.The customer will send in the unit to be exchanged.There was no patient injury reported.Investigation summary: nihon kohden (nk) received the device on 06/09/2023.The nk repair center (rc) evaluated the device on 09/12/2023.The nk rc connected the unit to a cns, tested the unit for over 24 hours, and could not duplicate the complaint.A definitive root cause could not be determined since the complaint could not be duplicated.Additional information: b4 date of this report.D9 device available for evaluation? g3 date received by manufacturer.G6 type of report.H2 if follow up, what type? h3 device evaluated by manufacturer? h10 additional manufacturer narrative.Manufacturer references # (b)(4) follow up 001.

• Brand Name: GZ-130PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 116-8 560; JA 116-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 17088792
• MDR Text Key: 317084060
• Report Number: 8030229-2023-03601
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921117415
• UDI-Public: 04931921117415
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GZ-130PA
• Device Catalogue Number: GZ-130PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CNS; CNS